Parenteral solution equipment and method of using same



May 8, 1962 J. w. RICHTER ETAL PARENTERAL SOLUTION EQUIPMENT AND METHOD OF usmc SAME Filed Oct. 7', 1955 INVENTORS.

JOHN W. RICHTER EDWARD J. NAWOJ United States Patent Ofiiice 3,033,202 PARENTERAL SOLUTION EQUIPMENT AND METHOD OF USING SAME John W. Richter, Niles, and Edward J. Nawoj, Mount Prospect, 111.; said Richter assignor to Baxter Laboratories, Inc., Morton Grove, 111.

Filed Oct. 7, 1955, Ser. No. 539,145 4 Claims. (Cl. 128-272) This invention relates to parenteral solution equipment and the method using the same and, more particularly, to container equipment adapted to unit parenteral medicaments just prior to administration thereof.

Inasmuch as parenteral solutions are commonly used in surgical procedures they have been found to provide convenient vehicles for supplemental administration. Where, for example, the surgeon desires to administer a parenteral anesthetic, skeletal muscle relaxant, anti-biotic, or the like, and a parenteral solution regimen such as saline is also contemplated, it is distinctively advantageous to combine the two. This eliminates the need for making an additional vein puncture which is oftentimes painful and inconvenient.

To achieve the foregoing, we have invented parenteral solution equipment including a container for the supplemental medicine which is adapted to introduce the medicine into an already-provided parenteral solution bottle, the introduction being performed under substantially aseptic conditions and without loss of the medicine which is usually expensive and carefully controlled in quantity.

Our invention will be explained in conjunction with the accompanying drawing in which FIG. 1 is a perspective View of the container of our invention in combination with a parenteral solution bottle; FIG. 2 is an enlarged cross-sectional view of the container of FIG. 1; FIG. 3 is a view similar to FIG. 2 but showing the container in an operative condition; and FIG. 4 is a perspective view of the pumping member of the container in the condition seen also in FIG. 3.

Referring now to the drawing and, in particular, to FIG. 1, the numeral designates generally a container for a supplemental medicament which also might be termed an additive vial. Vial 10 includes a glass container 11 having a mouth at one end. Closing the mouth of container :11 is a resilient dispensing closure member 12 secured to container 11 by clamping ring 13, all of which can be seen more clearly from a consideration of FIG. 2.

In FIG. 2 dispensing closure 12 is seen to include a resilient diaphragm 14 which covers the mouth of container 11. In the embodiment shown, diaphragm 14 is provided with a depending annular skirt 15 which permits convenient positioning of diaphragm 14 within the mouth of container 11. Diaphragm 14 is also provided with an annular upstanding shoulder 16 which, in combination with the annular head 17 of container 11, permits securement of diaphragm 1 4 to container 11 by clamping ring 13. This securement is readily achieved by providing ring 13 in the form of a metal collar and rolling the lower edge as at 13a to grip bead 17.

Diaphragm 14 is provided with a centrally positioned aperture 13 which permits outflow of supplemental medicament 19. In the embodiment shown in FIG. 2, aperture or passage 18 is closed by hinged valve 18a which is provided integral with diaphragm 14. In one embodiment we provide an aperture of about 0.20" internal diameter with valve 18a hinged as at 18b (better seen in FIG. 3) by an integral strap of about A width. As can be seen from the drawing, the hinged valve 18a is upsettable and is provided by an interrupted circular slit or groove in the diaphragm 14.

Integral with diaphragm 14 and extending outwardly therefrom is a neck-like portion 20. Neck-like portion 20 is positioned about aperture 18 and is adapted to receive dispensing spout 21 and hold the same in a substantially airtight grip achieved by integral male threads 21a. Prior to use of the thus assembled container 19, we provide a protector cap as indicated at 22 to close off the puncturing end of spout 21. We also provide annular flange 211; on spout 21 to serve as a gripping means for insertion and removal of spout 21 from the outlet passage of a parenteral solution bottle stopper.

The use of the container 10 can be appreciated with a consideration of FIG. 1 wherein the spout 21 of container 10 is shown positioned above the dispensing closure portion of a parenteral solution bottle prior to insertion therein. Medicament 19 can be forced downwardly through aperture 18 and the bore of spout 21 merely by pumping container 10. The pumping action referred to involves a relative longitudinal movement of container 10 with respect to the larger parenteral solution bottle so as to cause resilient diaphragm 14 to flex, thereby varying the internal volume of container 10.

The parenteral solution bottle hereinbefore referred to is designated 23 and contains a parenteral solution 24. Bottle 23 is provided with rubber stopper 25 mounted in its neck and provided with an annular flange 26 overlying the upper lip of bottle 23. Securing stopper 25 in the neck portion of bottle 23 is clamping ring 27 which is rolled on in a fashion similar to that outlined above with respect to container 10. An annular bead (not shown) of bottle 23 provides the anchoring means for clamping ring 27. Overlying stopper 25 is frangible rubber disc 28.

Extending through stopper 25 is a solution outlet passage (not shown but indicated by vacuum dimple 29 in disc 28).

Also extending through stopper 25 is a second passage constituting an air inlet during administration of solution 24. Mounted in this second passage and extending inwardly of bottle 23 is air tube 30. When solution 24 is to be administered, bottle 23 is mounted in mouth downward fashion by means of a suspension device consisting of bail 31 and band 32 so that air tube 30 permits air to enter bottle 23 to replace solution 24 discharged through the outlet passage of stopper 25.

When it is desired to supplement solution 24 with a medicament of the character hereinbefore described or with one that is relatively unstable when provided in a solution form, it is merely necessary to insert spout 21 of medicament containing vial 10 into the outlet passage of stopper 25. Spout 21 can be adapted to puncture any frangible closure means overlying stopper 25 such as disc 28 in the event such closure means is not removed prior to use.

Operation Once spout 24 has been inserted into the outlet passage indicated by dimple 29 as outlined immediately above, it is only necessary to thrust down lightly on vial It) to cause medicament 19 to be forced out of vial 10 into bottle 23. The same downward movement causes necklike portion 20 to move toward the interior of vial 10, dislodging valve 18a from its seat in aperture 18. The portion of diaphragm 14 adjacent neck-like portion 20 tends to become folded or telescoped as seen from FIG. 3. This rolling of diaphragm 14 aids in opening valve 18a. 'In this fashion, none of the medicament 19 is lost since vial 10 is essentially a closed container until communication between it and bottle 23 is established.

The above procedure is followed when medicament 19 is a liquid, and in the event all medicament is not forced into bottle 19 by one thrust, subsequent relative movemeat of vial 10 with respect to bottle 23 causes the remaining medicament to flow through spout 20 into bottle 23. We prefer to refer to this as a pumping action since the inward flexing of diaphragm 14 results in a smaller internal volume in vial 10 with an attendant increase in pressure.

In an analogous fashion, medicament 19, if a solid, can be transferred. Such may be the case where it is impossible to provide certain drugs in a stable liquid form. When medicament 19 is a solid it can be transferred by inverting the united containers so that the additive vial is lowermost. Thrusting vial 10 upwardly causes valve 19:: to open and solution 24 from bottle 23 to run into vial 10' Upon reinversion of the united containers, solution-borne solid medicament 19 can be pumped out of vial 10 as set forth above with respect to the operation involving a medicament originally provided in liquid form.

The foregoing detailed description has been given for clearness of understanding only and no unnecessary limitations are to be inferred therefrom.

We claim:

1. In the combination of a parenteral solution bottle equipped with a resilient closure and an additive vial for penetrating said closure for supplementing the parenteral solution in said bottle, an improved vial characterized by the fact that it includes an elongated, rigid spout having a pointed end portion and a flow passage extending longitudinally therethrough, a resilient cup-shaped pump having oppositely-disposed closed end and open end portions, with an opening in the center of the closed end portion, and a generally cylindrical solute material container connected to said open end portion, said pump being equipped with a tubular portion integrally and centrally located on said closed end portion and extending along the axis of said solute material container, said spout being mounted in said tubular portion and defining therewith a projection extending outwardly of the connected pump and solute material container, means associated with said projection for manipulating said projection, said pump being equipped with an open-able barrier extending across said opening to close the same, said barrier including a flap equipped with a hinge portion, said hinge portion being integral with said flap and pump, said flap conforming in outline to said opening, whereby said barrier is openable by movement of said spout along the axis of said solute material container and inwardly relative to said solute material container.

2. In the combination of an additive container and the parenteral solution container having a penetrable stopper through which additive material is introduced from the additive container to a parenteral container, the improvement which comprises an additive container of the character described, comprising: an elongated tubular dispensing container spout having a rigid, pointed stopper-puncturing end portion and having a flow passage extending longitudinally therethrough; a resilient cup-shaped pump having a deformable closed end portion with a centrally located opening connected with the end of said spout opposite said pointed end portion, said pump having an open end portion spaced axially of the pump from said opening, a generally cylindrical additive material container connected with the open end of said pump and having an axis generally coaxial with the axis of said cup-shaped pump and of said tubular spout, an enlarged flange-like portion on said spout intermediate the ends thereof and extending outwardly therefrom generally transversely of the spout axis, said pump adjacent said opening being equipped with an integral hinged portion normally closing said opening, said hinged portion being defined by an interrupted, generally circular groove in said closed end portion whereby when said additive material container is inverted, discharge of its contents is prevented until said spout is moved inwardly of said container to move inwardment additive material from an additive container into a quantity of parenteral liquid in a dispensing container having a penetrable stopper, the improved additive container assembly connectable with said dispensing con-- tainer through penetration of said stopper, comprising: an elongated tubular dispensing container adapter having a rigid, pointed stopper-puncturing end portion and hav ing a flow passage extending longitudinally therethrough; a cup-shaped pump having a deformable closed end portion constructed of resilient material with a centrally located opening theretnrough connected with the end of said adapter opposite said pointed end portion, said pump having an open end portion spaced axially of the pump from said opening; and a generally cylindrical additive material container connected with the open end of said pump and having an axis generally coaxial with the axis of said cup-shaped pump and of said tubular adapter, said pump being equipped with a pivotally mounted flap valve element normally closing said opening, said valve element being integrally formed with said pump and being defined by an interrupted circular groove in said closed end portion to provide both said opening and an upsettable hinged portion connecting said valve element to said pump closed end portion whereby inward movement of said adapter moves an annular part of said closed end portion inwardly to pivot said flap valve element inwardly.

4. in the combination of a parenteral solution bottle equipped with a resilient closure and an additive vial for penetrating said closure for supplementing the parenteral solution in said bottle, the improved additive vial characterized by the fact that it includes a generally cylindrical vi'al having a mouth, a resilient diaphragm extending across said month, an elongated tubular projection integral with said diaphragm and extending axially outwardly of said cylindrical vial, means spaced from said projection securing said diaphragm to said vial and thereby defining an annular portion of said diaphragm positioned between said projection and said securing means, a passage in said projection extending longitudinally thereof, a rigid tubular dispensing spout having a first portion of its length tightly mounted in said tubular projection passage, the remaining portion of said spout terminating in a pointed end, said spout and diaphragm forming an additive container assembly, means on the exterior surface of said assembly intermediate the diaphragm annular portion and spout pointed end providing a mauually-manipulatable surface portion for facilitating the penetration of said spout through said closure and for limiting the insertion of said spout, and a dislodgeable barrier associated with said passage and normally closing the same, the annular portion of said diaphragm about said tubular portion being movable inwardly of said vial upon axial inward movement of said dispensing spout and projection to dislodge said barrier, said inward movement reducing the interior volume of said vial to effect a pressure expulsion of the vial contents into said bottle.

References Cited in the file of this patent UNITED STATES PATENTS 448,070 Perry Mar. 10, 1891 1,152,601 Carpenter Sept. 7, 1915 2,263,890 Salvesen Nov. 25, 1941 2,362,103 Smith Nov. 7, 1944 2,393,322 Houghton Jan. 22, 1946 2,580,836 Rausch Jan. 1, 1952 FOREIGN PATENTS 1,010,029 France Mar. 12, 1952 

